The FDA has accepted a new drug application for IDP-123, a lotion for the treatment of acne, according to an announcement from Bausch Health and Ortho Dermatologics, Bausch’s dermatology business.
The NDA for IDP-123 (tazarotene 0.045%) includes data from two phase 3 randomized, placebo-controlled, double-blind clinical trials of 1,614 patients with moderate to severe acne. All primary endpoints were met with statistical significance, including an absolute change in the mean noninflammatory and inflammatory lesion counts and the percentage of subjects who had a least a two-grade improvement from baseline to week 12 in the Evaluator Global Severity Score and who had “clear” or “almost clear” skin, according to a press release.
In addition, the lotion was well tolerated by patients.
The PDUFA action date is Dec. 22, and if approved, IDP-123 will be the first tazarotene acne treatment available in lotion form, the release said.